At a Glance
- Tasks: Coordinate risk management in clinical trials to ensure data integrity and patient safety.
- Company: Join a leading healthcare company committed to quality and innovation.
- Benefits: Competitive salary, inclusive culture, and opportunities for professional growth.
- Other info: Flexible work environment with potential for travel and diverse team collaboration.
- Why this job: Make a real impact on patient safety and trial success in a dynamic environment.
- Qualifications: Bachelor's degree and 6 years in healthcare; strong communication and teamwork skills required.
The predicted salary is between 60000 - 75000 £ per year.
The Senior Specialist, Clinical Risk Management works with trial teams to coordinate the identification, assessment, and mitigation of quality risks that could impact trial data integrity, patient safety, well-being, or rights. Throughout the trial, the Senior Specialist executes data-driven, risk-based trial oversight activities to deliver quality in execution of trials, compliance with regulatory requirements and internal procedures, and maintain inspection readiness.
Key Responsibilities:
- Actively participates in all study activities, contributing to the identification and assessment of key risks in the clinical protocol/set-up and advising clinical team members on effective mitigation strategies.
- Participates in regular review of risk areas in collaboration with Risk Owners, to evaluate progress of risk mitigations and risk reduction, and to identify potential new risks or additional mitigation needs (trial and/or compound, as assigned).
- Maintains CQP (Clinical Quality Plans) in quality repository to facilitate regular progress reviews of quality support services in addition to risks and mitigations.
- Collaborates closely with risk owners in evaluation of mitigation actions and effectiveness checks on mitigations.
- Communicates and facilitates risk updates to R&D colleagues as part of the regular review cycle through Quality Working Groups and Governance Fora, as applicable (trial and/or compound, as assigned).
- Highlights new potential systemic risk to RDQ CRM management.
- Develops and ensures a consistent interpretation of issues that require quality investigations.
- Provides guidance for significant quality issues (SQI) per corporate standards and escalates SQI to senior R&D management.
- Provides initial serious breach evaluation of quality issue that may require reporting to Health Authorities.
- In collaboration with partners in RDQ, provides advice on the development and implementation of Corrective and Preventative Action (CAPA) Plans and Effectiveness Checks (Self-Identified, Inspection, Audit).
- Supports proactive inspection readiness activities throughout the study with trial teams to develop ongoing trial oversight, inspection narratives, identify and prepare sites of interest for inspection (including pre-inspection visit support), ensures availability of key documents/records and coordinates mock inspection in collaboration with Regulatory Compliance teams.
- Provides support for Investigator, Sponsor-Monitor and third-party inspections including post-inspection support.
- Provides advice on questions related to research quality and compliance from Business Partners in collaboration with other Quality Professionals and Subject Matter Experts to ensure consistent interpretation of international regulations and policy.
Qualifications:
- A minimum of a Bachelor’s degree (scientific, medical, or related discipline) is required.
- A minimum of 6 years working in the healthcare industry (pharmaceutical industry, contract research organization, and/or healthcare/hospital system) is required.
- Excellent interpersonal, oral, and written communication skills.
- GCP quality and/or clinical trials experience.
- Experience collaborating in a cross-functional team environment.
- Flexibility to respond to changing business needs is required.
- Demonstrated ability to operate in an environment of culturally diverse styles and business approaches by understanding regional and global business structures is required.
- Proficiency in Microsoft Office Applications is required.
- Experience with fundamentals of clinical trial risk management, preferably in a global setting.
- Experience working to ICH guidelines.
- Health Authority Inspection experience (FDA, EMA and other inspectorates).
- Strong Project Planning/Management skills.
- Experience and/or proficiency with data analytics and/or data visualization tools (e.g., Tableau, Spotfire, or related).
- Proven ability to analyze & interpret collective data to provide insights to drive decision-making.
- Experience in managing escalations and CAPA support/advisement.
- Experience with Data Science and Digital Health (including Real World Evidence/Real World Disease).
- Requires proficiency in speaking and writing English.
- Up to 10% travel, primarily domestic with some international travel.
Preferred Skills:
- Audit Management
- Business Alignment
- Business Savvy
- Clinical Research and Regulations
- Clinical Trials Operations
- Coaching
- Collaboration
- Communication
- Compliance Management
- Data Analysis
- Escalation Management
- Fact-Based Decision Making
- Problem Solving
- Quality Control (QC)
- Quality Management Systems (QMS)
- Quality Standards
- Tactical Thinking
- Vendor Selection
Senior Specialist, Clinical Risk Management employer: Johnson & Johnson Innovative Medicine
At Johnson & Johnson, we pride ourselves on being an exceptional employer, particularly for the Senior Specialist, Clinical Risk Management role based in High Wycombe. Our commitment to employee growth is evident through our supportive work culture that fosters collaboration and innovation, alongside comprehensive benefits that prioritise well-being and work-life balance. With a focus on quality and compliance in clinical trials, you will have the opportunity to make a meaningful impact while working in a diverse environment that values your contributions and encourages professional development.
Contact Details:
Johnson & Johnson Innovative Medicine Recruitment Team
StudySmarter Expert Advice🤫
We think this is how you could land Senior Specialist, Clinical Risk Management
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We think you need these skills to ace Senior Specialist, Clinical Risk Management
Some tips for your application 🫡
Highlight Your Relevant Experience:When applying for a role in health sciences administration, it's super important to spotlight any relevant experience you have in healthcare settings. Whether you've worked in a hospital, a clinic, or any related environment, make sure to detail those roles in your CV – focusing on your responsibilities and achievements that align with the job at Johnson & Johnson Innovative Medicine.
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Tailor Your Documents to the Job:Don't use a one-size-fits-all approach! Make sure your CV and cover letter are specifically tailored for this role. Highlight any certifications you have relevant to health administration, and ensure you clearly connect your previous roles to the skills needed for the full-time position at Johnson & Johnson Innovative Medicine. This way, you're showing them you’ve done your homework and are genuinely interested in being a part of their team.
How to prepare for a job interview at Johnson & Johnson Innovative Medicine
✨Showcase Your Administrative Skills
In health sciences administration, being organised is key. Make sure you can demonstrate your skills in managing schedules, paperwork, and data accurately. Be ready to discuss specific tools you've used, like electronic health record systems or scheduling software, and how they improved efficiency in your past experiences.
✨Know Your Regulations
Familiarity with healthcare regulations and compliance is crucial. Brush up on HIPAA, GDPR, or other relevant policies before your interview. We recommend preparing examples of how you've ensured compliance or handled sensitive information in past roles—this will show you're not just knowledgeable but also responsible.
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✨Align Your Goals with the Organisation
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